Overview
On December 5, 2025, the CDC’s Advisory Committee on Immunization Practices (ACIP)—recently overhauled under Health and Human Services Secretary Robert F. Kennedy Jr.—voted 8–3 to end the longstanding recommendation that every U.S. newborn receive a hepatitis B vaccine dose within 24 hours of birth. For babies whose mothers test negative for hepatitis B, the panel now advises “individual-based” (shared) decision-making with parents and suggests delaying the first dose until at least two months of age, while retaining the birth dose for infants whose mothers are infected or whose status is unknown.
The move reverses a core element of a 1991 strategy credited with driving a ~98–99% decline in hepatitis B infections among U.S. children, and it comes after Kennedy purged and repopulated ACIP with several vaccine-skeptical figures earlier in 2025. Major medical societies, vaccine makers, state health officials, and former ACIP members warn the change could increase perinatal and early-childhood hepatitis B, particularly where maternal screening fails, and see it as a test case for broader rollbacks of the childhood immunization schedule ordered by President Trump. The recommendation will only take effect if adopted by acting CDC Director Jim O’Neill, setting up a high-stakes choice with national repercussions for hospital protocols, insurance coverage, and public trust in vaccines.
Key Indicators
People Involved
Organizations Involved
The CDC is the U.S. federal agency responsible for disease surveillance, outbreak response, and public health guidance, including the official childhood immunization schedule.
ACIP is the expert advisory body that reviews evidence on vaccines and proposes recommendations to the CDC director on how vaccines should be used in the United States.
HHS oversees federal health agencies, including CDC, and under Secretary Kennedy has aggressively reoriented national vaccine policy.
AAP represents U.S. pediatricians and develops clinical policy statements on child health, including immunization recommendations.
AASLD, together with ACG, AGA, ASGE, IDSA, and NASPGHAN, represents liver-disease specialists, gastroenterologists, and infectious-disease physicians.
Timeline
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Trump orders review of U.S. childhood vaccine schedule
Executive ActionFollowing the ACIP vote, President Trump orders a federal review of the U.S. childhood vaccine schedule, asserting that the United States is an "outlier" in the number of vaccines administered and signaling potential further rollbacks beyond hepatitis B.
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Sen. Bill Cassidy urges CDC to reject ACIP change
Political ResponseSenator and hepatologist Bill Cassidy, chair of the Senate HELP Committee, calls ACIP’s move a mistake and urges acting CDC Director Jim O’Neill not to sign the new recommendation, warning it will result in more hepatitis B infections and liver disease.
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Backlash from medical groups, states, and vaccine makers
ReactionThe American Academy of Pediatrics, American Medical Association, liver and infectious-disease societies, and state health departments in Colorado and Oregon publicly oppose the ACIP decision and urge maintaining universal newborn vaccination. Merck and GSK, makers of hepatitis B vaccines, warn that the change threatens decades of progress and could lead to more infections and deaths.
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ACIP votes 8–3 to end universal hepatitis B birth-dose recommendation
Policy DecisionAfter contentious debate, ACIP votes 8–3 to replace the universal newborn hepatitis B birth-dose recommendation for infants of hepatitis B–negative mothers with "individual-based decision-making" and suggests delaying the first dose until at least two months of age. Birth-dose recommendations for infants of infected or unknown-status mothers remain unchanged.
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ACIP delays initial vote amid confusion over hepatitis B language
MeetingDuring an ACIP session in Atlanta, members express frustration that last-minute changes have left them unclear on what exactly they are voting on regarding the hepatitis B birth dose. The panel votes 7–3 to delay the decision until the next day.
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Liver and infectious-disease societies warn against abandoning birth dose
Professional ResponseAASLD and five partner societies issue a joint statement calling ACIP’s planned move to scrap universal hepatitis B birth-dose recommendations alarming and urging that the birth dose be maintained to prevent thousands of infections and tens of thousands of deaths.
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ACIP backs universal hepatitis B testing in pregnancy, delays birth-dose vote
PolicyACIP votes to recommend that all pregnant women be tested for hepatitis B, a step that will be covered by federal insurance programs, but amid confusion over draft language, the committee tables a vote on whether to change the universal newborn birth-dose recommendation.
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Reconstituted ACIP targets childhood schedule for review
MeetingAt its first meeting under new leadership, ACIP chair Martin Kulldorff announces that workgroups will re-examine the U.S. childhood immunization schedule and long-approved vaccines, explicitly questioning whether it is "wise" to give every newborn a hepatitis B shot before discharge.
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New ACIP members named, including vaccine skeptics
GovernanceHHS unveils eight new ACIP advisers, including Martin Kulldorff, Joseph Hibbeln, Robert Malone, and Cody Meissner. Critics warn the panel could now undermine long-established vaccine recommendations, including for hepatitis B.
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HHS reconstitutes ACIP, firing all 17 members
GovernanceKennedy announces that all 17 ACIP members have been "retired" and that the committee will be fully reconstituted, arguing that a clean sweep is needed to restore public trust and eliminate conflicts of interest.
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Reports emerge that RFK Jr. plans ACIP shake-up
GovernanceBloomberg Law reports that HHS Secretary Robert F. Kennedy Jr. is moving to remove the sitting members of ACIP as part of a broader effort to revamp vaccine approvals and oversight.
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AAP policy calls for hepatitis B birth dose within 24 hours
Clinical GuidanceThe American Academy of Pediatrics issues a policy statement endorsing ACIP’s recommendation that all infants ≥2,000 g receive the first hepatitis B dose within 24 hours of birth, describing it as a critical safety net against perinatal transmission and maternal testing failures.
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ACIP tightens guidance: birth dose before hospital discharge
PolicyACIP revises recommendations to specify that all medically stable newborns weighing at least 2,000 g receive a hepatitis B vaccine dose before hospital discharge, further institutionalizing the birth dose as a universal practice.
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Temporary delay of hepatitis B birth dose over thimerosal concerns
PolicyThe American Academy of Pediatrics and the U.S. Public Health Service recommend postponing the first hepatitis B dose until age 2–6 months for infants of hepatitis B–negative mothers to reduce exposure to thimerosal, a mercury-containing preservative, while maintaining a birth dose for infants of infected or unknown-status mothers. By September 1999, thimerosal-free vaccine becomes available and CDC urges resumption of routine newborn vaccination, but coverage remains depressed for months and confusion persists.
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ACIP endorses universal infant hepatitis B vaccination
PolicyACIP issues a comprehensive strategy to eliminate hepatitis B virus transmission in the United States, recommending hepatitis B vaccination for all infants, with the first dose administered during the newborn period, preferably before hospital discharge but no later than two months of age.
Scenarios
CDC Director Adopts ACIP Recommendation; Universal Birth Dose Quietly Ends
Discussed by: Reuters, Scientific American, MarketWatch, Time, multiple public health commentators
In this scenario, acting CDC Director Jim O’Neill signs off on ACIP’s December 2025 recommendation without major modification. The official childhood immunization schedule drops the universal birth-dose language for infants of hepatitis B–negative mothers and adopts individual-based decision-making with a suggested start at or after two months. Hospitals and pediatric practices face conflicting signals: federal guidance becomes more permissive, but major medical societies and some state health departments continue to advocate universal birth dosing. Over several years, birth-dose coverage declines unevenly—more sharply in under-resourced settings—leading to increases in early-childhood hepatitis B infections, especially when maternal screening is missed or seroconversion occurs late in pregnancy. Modeling suggesting hundreds to more than a thousand additional infections annually begins to be borne out in surveillance data.
CDC Modifies or Rejects ACIP Guidance Under Political and Professional Pressure
Discussed by: Senate HELP Committee discussions, commentary in major newspapers, statements by AAP/AASLD and other medical societies
Here, sustained pushback from medical societies, vaccine manufacturers, state health officials, and key lawmakers such as Sen. Bill Cassidy persuades Jim O’Neill to either delay adoption or issue a modified recommendation. The CDC could, for example, retain a strong universal-birth-dose recommendation while adding language encouraging shared decision-making, or it could request additional evidence before endorsing a delay to two months. Such a move would be highly unusual—CDC directors rarely override ACIP—but not impossible given the controversy and questions about the new committee’s scientific rigor. This outcome would preserve national guidance for universal newborn hepatitis B vaccination while intensifying political conflict between HHS leadership, the White House, and career public health officials.
States and Professional Societies Preserve De Facto Universal Birth Dose Despite Federal Shift
Discussed by: State health departments (e.g., Colorado, Oregon), AAP and specialty-society statements, health-policy analysis
Even if the CDC adopts ACIP’s recommendation, states, hospital systems, and professional organizations may effectively maintain a universal hepatitis B birth-dose standard in practice. State health departments can issue their own guidance, hospitals can retain standing orders to vaccinate all newborns, and school-entry or childcare immunization requirements can continue to assume a completed three-dose series that begins at birth. In this scenario, coverage remains high in states and systems that resist the change but erodes elsewhere, creating geographic and socioeconomic disparities in protection. Over time, pockets of under-vaccination could see outbreaks or clusters of early-childhood hepatitis B, while national incidence remains relatively low, fueling ongoing debate over the real-world impact of the policy change.
Hepatitis B Birth-Dose Decision Becomes Template for Broader Vaccine Rollbacks
Discussed by: Washington Post, Politico, CNBC, public health and legal scholars analyzing Kennedy’s agenda
In this more expansive scenario, the successful rollback of the hepatitis B birth-dose recommendation emboldens the reconstituted ACIP and the Trump administration to target other elements of the childhood immunization schedule. Under the executive order to review the schedule and Kennedy’s stated plan to re-examine long-approved shots, ACIP moves to narrow recommendations for vaccines such as MMR, varicella, or HPV, or to emphasize parental discretion over universal guidance. The hepatitis B case becomes both precedent and political proof-of-concept that long-standing recommendations can be reversed despite opposition from mainstream medical organizations. Over the medium term, this leads to declining coverage for multiple vaccines in some regions, greater state-to-state divergence, and an increased risk of outbreaks of several vaccine-preventable diseases.
Historical Context
1999 U.S. Suspension of the Hepatitis B Birth Dose Over Thimerosal
July 1999 – mid-2000What Happened
In July 1999, amid theoretical concerns about mercury exposure from thimerosal-containing vaccines, the American Academy of Pediatrics and the U.S. Public Health Service recommended postponing the first hepatitis B dose until 2–6 months of age for infants whose mothers tested negative for hepatitis B, while maintaining birth dosing for infants of infected or unknown-status mothers. Within months, thimerosal-free hepatitis B vaccines became available, and CDC urged hospitals to resume routine birth dosing. Nevertheless, studies found that birth-dose coverage and completion of the three-dose series fell substantially for infants born during and shortly after the suspension, reflecting confusion created by rapidly changing guidance.
Outcome
Short term: Birth-dose coverage dropped sharply and remained depressed for months after the recommendation was rescinded; hundreds of thousands fewer newborns received timely hepatitis B vaccination, and more children were under-vaccinated by 19 months of age.
Long term: Over the following years, universal birth-dose recommendations were reaffirmed, thimerosal was largely removed from pediatric vaccines, and coverage gradually recovered. The episode is now cited as a cautionary tale about the lasting impact of abrupt, poorly communicated vaccine-policy changes.
Why It's Relevant
The 1999 suspension shows how even temporary, narrowly targeted changes to hepatitis B birth-dose guidance can reduce coverage and sow long-lasting confusion. The 2025 ACIP decision goes further—abandoning universal birth-dose recommendations for a large segment of infants—raising concerns that the coverage and trust losses could be deeper and more sustained.
Japan’s Suspension of Proactive HPV Vaccine Recommendations
2013 – 2021 (with continuing effects)What Happened
In June 2013, Japan’s Ministry of Health, Labour and Welfare suspended its proactive recommendation for the HPV vaccine following media reports of alleged adverse events, even though subsequent reviews found no causal link. Routine vaccination technically remained available, but uptake among adolescent girls plummeted from more than 70% to below 1% within months, creating a so-called "lost generation" of unvaccinated young women. Modeling studies project that the prolonged suspension will result in more than 20,000 excess cases of cervical cancer and over 5,000 additional deaths.
Outcome
Short term: Coverage collapsed and stayed extremely low for years despite scientific evidence supporting vaccine safety, as official ambivalence reinforced public fear and undermined trust.
Long term: Japan resumed proactive HPV vaccine recommendations in 2021, and catch-up campaigns are under way, but the country faces a long-term burden of preventable cervical cancer in cohorts who missed vaccination.
Why It's Relevant
Japan’s experience illustrates how retreating from strong, proactive vaccine recommendations—without clear scientific justification—can drive dramatic, long-lived declines in uptake and substantial future disease burden, even if vaccines remain available on paper. Critics of the 2025 ACIP decision fear a similar dynamic for hepatitis B birth dosing in the U.S.: a shift from universal recommendation to "it’s your choice" that, in practice, means many at-risk children go unprotected.
The UK MMR Vaccine Scare and Measles Resurgence
Late 1990s – mid-2000sWhat Happened
After the publication of Andrew Wakefield’s discredited 1998 paper claiming a link between the MMR vaccine and autism, MMR vaccination coverage in the United Kingdom fell from about 92% in 1996 to 84% in 2002, and in some London boroughs as low as 61% by 2003. In the years that followed, measles cases surged: confirmed cases rose from 56 in 1998 to hundreds per year, including the first measles death in the UK since 1992.
Outcome
Short term: Falling vaccine coverage led directly to measles outbreaks and severe illness in unvaccinated children, forcing public health campaigns and emergency responses.
Long term: Although coverage later improved after intense public-health efforts and the retraction of Wakefield’s paper, the episode left persistent vaccine hesitancy and highlighted how quickly hard-won herd immunity can be lost.
Why It's Relevant
The MMR saga underscores how politicized or poorly evidenced challenges to long-standing vaccine recommendations can erode uptake and trigger the return of controlled diseases. The 2025 hepatitis B decision similarly pits an expert consensus on safety and benefit against a reconfigured advisory body influenced by vaccine-skeptical narratives, raising fears of a slow-burning resurgence in a disease many clinicians now rarely see in children.